Covert-saccades, Dynamic Visual Acuity and Quality of Life (COSQOL)

• ClinicalTrials.gov Identifier: NCT02753179
• Recruitment Status: Completed
• First Posted: April 27, 2016
• Last Update Posted: January 16, 2017
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Tracking Information

• First Submitted Date: April 25, 2016
• First Posted Date: April 27, 2016
• Last Update Posted Date: January 16, 2017
• Study Start Date: May 2016
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2016)

Frequency of covert-saccades [ Time Frame: Day 0 ]

Frequency of covert saccades corresponds to the total amount of covert-saccades divided by the total amount of head impulse tests multiplied by 100.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 26, 2016)

• Quality of life assessed with the Dizziness Handicap Inventory [ Time Frame: Day 0 ]
  Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100
• Dynamic visual acuity [ Time Frame: day 0 ]
  Dynamic visual acuity is a measure of threshold for binocular reading of letters that are presented on a screen during head impulse test
• Oscillopsia severity questionnaire score [ Time Frame: day 0 ]
  Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances. A mean item score gives an oscillopsia severity score ranging from 1 to 5, yielding to a total score ranging from 0 to 45
• Latency of covert-saccades [ Time Frame: Day 0 ]
  Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Covert-saccades, Dynamic Visual Acuity and Quality of Life
• Official Title: Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades
• Brief Summary: Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Vestibular Diseases

Intervention

• Other: Head Impulse Tests
  Head Impulse Tests are performed by the clinician who holds the patient's head in his hands, while he is looking straight at an earth-fixed target; then by turning the patient's head abruptly and unpredictably to the left or right, up or down through a small angle (only 10-20 degrees - not a large angle). 20 impulses in each directions (6) will be performed.
• Other: Dynamic visual acuity Test (DVAT)
  Dynamic visual acuity Test (DVAT) assesses visual acuity during head movement relative to baseline static visual acuity. DVA will be assessed actively during self-generated rotations of the head in different directions.
• Other: VEMPs & VEMPo
  VEMPs & VEMPo are sound evoked muscular contractions of the neck or eye. They are recorded using an evoked response computer, a sound generator, and surface electrodes to pick up neck or eye muscle activation.
• Other: Dizziness Handicap Inventory
  Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100
• Other: Oscillopsia severity questionnaire
  Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.

Study Arms

Experimental: Bilateral vestibular hypofunction

Patients suffering from chronic bilateral vestibular hypofunction.

Interventions:

• Other: Head Impulse Tests
• Other: Dynamic visual acuity Test (DVAT)
• Other: VEMPs & VEMPo
• Other: Dizziness Handicap Inventory
• Other: Oscillopsia severity questionnaire

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 26, 2016): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria

  • Mean peak slow phase velocity of 5°/s or less in bilateral bithermal (30 and 44°C) caloric irrigations
  • Pathologic Head-impulse test
  • VOR gain of <0.25 on rotatory chair tests
• Disorder present for over 6 month
• Comprehension of the experiments instructions
• Patient consent

Exclusion Criteria:

• Corrected Visual Acuity lower than 5/10
• Other conditions leading to oscillopsia or ataxia
• Oculomotor palsy, ocular instability in primary position
• Cervical rachis pathology with instability
• Cochlear Implants
• Non-stabilized medical disease
• Pregnant women
• Patients under tutelage

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02753179
• Other Study ID Numbers: 69HCL15_0746
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hospices Civils de Lyon
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospices Civils de Lyon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Caroline TILIKETE, MD; Institut National de la Santé Et de la Recherche Médicale, France

• PRS Account: Hospices Civils de Lyon
• Verification Date: January 2017